Patient Information Sheet
Darifenacin (marketed as Enablex)

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This is a summary of the most important information about Enablex. For details, talk to your health care professional.

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What is Enablex?

Enablex is a prescription medicine used in adults to treat the following symptoms due to a condition called overactive bladder:

• having a strong need to go to the bathroom right away, also called ?urgency?

• leaking or wetting accidents, also called ?urinary incontinence?

• having to go to the bathroom too often, also called ?urinary frequency?

Enablex has not been studied in children.

Who Should Not Use Enablex?

Do not take Enablex if you:

• are not able to empty your bladder (also called ?urinary retention?)

• have delayed or slow emptying of your stomach (also called ?gastric retention?)

• have an eye problem called ?uncontrolled narrow-angle glaucoma?

•  are allergic to Enablex or any of its ingredients.

What are The Risks?

The most common side effects of Enablex are dry mouth and constipation.

Other less common side effects include:

• Blurred vision. Use caution while driving or doing dangerous activities until you know how Enablex affects you.

• Heat prostration due to decreased sweating can occur when drugs such as Enablex are used in a hot environment.

What Should I Tell My Health Care Professional?

Before you start using Enablex, tell your health care professional if you:

• have any stomach or intestinal problems, or problems with constipation

• have trouble emptying your bladder or you have a weak urine stream

• have an eye problem called narrow angle glaucoma,

• have liver problems

• are pregnant or trying to become pregnant, or are breastfeeding

Are There Any Interactions With Drugs or Foods?

Enablex can interact with certain other medicines. Know the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Keep a list of them to show your healthcare professional.

Your healthcare professional may have to adjust your dose or watch you more closely if you take the following medicines:

• ketoconazole (Nizoral) or itraconazole (Sporonox), antifungal medicines

• clarithromycin (Biaxin), an antibiotic medicine

• ritonivir or nelfinavir (Viracept), antiviral medicines

• nefazadone (Serzone), a depression medicine

• flecainide (Tambocor), an abnormal heartbeat (antiarrhythmia) medicine

• thioridazine (Mellaril), a mental disorder (antipsychotic) medicine

• a medicine called a tricyclic antidepressant

How Do I Take Enablex?

• Take Enablex exactly as prescribed. Your doctor may prescribe the lowest dose if you have certain medical conditions such as liver problems.

• You should take Enablex once a day with liquid.

• Enablex should be swallowed whole and not chewed, divided or crushed.

• Enablex may be taken with or without food.

Enablex FDA Approved 12/2004
Patient Information Sheet Revised 04/2005